FDA.reportPublic FDA data

RIDASCREEN® Norovirus 3rd Generation

Primary DI
04049095030079
Brand
RIDASCREEN® Norovirus 3rd Generation
Company
R-Biopharm AG
Model
C1401US
Catalog number
C1401US
Device description
The RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GI.2, GI.3, GI.4, GI.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks.
Published
2019-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUCNorovirus Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUCNorovirus Serological ReagentMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN110001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN110001000RIDASCREEN NOROVIRUS 3RD GENERATION EIAR-Biopharm AG2011-02-23OUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049095030079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095030079040490950300794049095030079

GMDN Terms#

Term, Definition table
TermDefinition
Norovirus antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Norovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321850323
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049095070495RIDASCREEN® Pancreatic Elastase ELISAG09038USAG09038USA2026-03-26
04049095160356RIDA®GENE Norovirus GI/GIIPG1445PG14452019-05-08
04049095260049RIDA® CCD-InhibitorZA06012023-07-03
04049095110023RIDASCREEN® Entamoeba histolytica IgGK1721K17212019-05-08
04049095110511RIDASCREEN® Echinococcus IgGK7621K76212019-05-08
04049095110528RIDASCREEN® Taenia solium IgGK7721K77212019-05-08